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Sr. Process Engineer/Sr. Manufacturing Engineer - Menlo Park, United States - Corcept Therapeutics
Description
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR).
In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing syndrome).Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases.
With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advance the possibilities of cortisol modulation.
What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
This position, reporting to the Sr. Director of Manufacturing, will be responsible for technical oversight of clinical and commercial manufacturing operations for pharmaceutical drug products. This role will also provide support when needed for drug substance manufacturing, supply chain, and analytical development activities.Responsibilities:
Support and oversee drug product manufacturing activities at Contract Manufacturing Organizations (CMOs), including development projects and routine manufacturing operations.
Provide "person-in-plant" support to oversee critical manufacturing activities at CMOs as needed.
Utilize technical expertise to troubleshoot manufacturing process issues.
Collaborate closely with Analytical and Quality colleagues, providing technical expertise to drive CMO investigations/deviations to successful resolution.
Assist in preparing reports detailing data analysis from manufacturing studies along with prospective solutions and benefits.
Review documents associated with drug product development and manufacturing, including but not limited to change controls, manufacturing batch records, protocols, investigations/deviations, and reports, and organize and archive documents in Veeva Quality Docs System.
Assist in authoring relevant sections, including formatting and structuring of data, in support of regulatory filings.Assist in drafting, formatting, and routing of SOPs for manufacturing.
Support activities to ensure Corcept complies with EHS requirements.
When needed, provide administrative support for activities related to packaging, supply chain, analytical development, and stability.
Support department approval of contracts and purchase orders.
Preferred Skills, Qualifications and Technical Proficiencies:
Working knowledge of documents related to GMP and development regarding Manufacturing, Analytical Development and Supply Chain.
Must have high proficiency in the use of MS Office applications (Word, Excel, PowerPoint).Detail-oriented, highly organized, a good initiative with a customer-service attitude.
Enjoy working independently.Interested in learning about technical aspects of CMC activitiesPreferred Education and Experience:
BA/BS degree in a scientific/technical/engineering field.3-5 years' experience in Pharmaceutical Manufacturing or equivalent.
The pay range that the Company reasonably expects to pay for this headquarters-based position is $123,100- $144,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at:
is an Equal Opportunity EmployerCorcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
